NCT00478972
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported in available records
pharma · Diphtheria · Diabetes Mellitus, Type 2
Sanofi Pasteur MSD
Sanofi Pasteur
Sanofi Pasteur is a pharma organization headquartered in LYON, FR. Primary therapeutic focus areas include Diphtheria, Diabetes Mellitus, Type 2, Japanese Encephalitis, Rabies, Hemophilia A. NovaPharmaNews links 83 clini
France, LYON HQ
363 Employees
EMA registrant Type
Company details
- Status
- Public
- HQ
- France, LYON
- Employees
- 363
- Programs
- 83
- Drugs
- 66
- Patents
- 0
Rimonabant
Phase 3 · small molecule · Obesity
Rimonabant (brand name ZIMULTI) is a small-molecule cannabinoid CB1 receptor antagonist developed by Sanofi Pasteur for the treatment of obesity. The drug works by blocking CB1 receptors, which are involved in appetite regulation and metabolic homeostasis. Rimonabant reached Phase 3 clinical development but the program
Internal code EFC6648
At a glance
- Sponsor
- Sanofi Pasteur
- Phase
- Phase 3
- Modality
- small_molecule
- Indication
- Obesity
- Status
- terminated
- Trials
- 1
Executive summary
Rimonabant (brand name ZIMULTI) is a small-molecule cannabinoid CB1 receptor antagonist developed by Sanofi Pasteur for the treatment of obesity. The drug works by blocking CB1 receptors, which are involved in appetite regulation and metabolic homeostasis. Rimonabant reached Phase 3 clinical development but the program was terminated, with the latest milestone recorded on 8 June 2016. The compound received European regulatory approval on 17 July 2008 under two EMA product numbers (EMEA/H/C/000666 and EMEA/H/C/000691) but was subsequently withdrawn from the EU market. The termination of the Phase 3 program and market withdrawal reflect challenges in the clinical or commercial development of the candidate, though specific reasons are not disclosed in available records. The obesity treatment landscape has evolved significantly since rimonabant's development, with newer mechanistic approaches now dominating the market.
Why this program matters
Obesity represents a substantial unmet medical need affecting millions globally, with limited pharmacological treatment options historically available. Rimonabant's CB1 antagonist mechanism offered a novel approach to appetite suppression and weight management distinct from existing therapies. The competitive landscape for obesity treatment has shifted markedly, with GLP-1 receptor agonists (such as semaglutide-based products and tirzepatide) now demonstrating superior efficacy and becoming standard-of-care agents. Other approved competitors in the obesity space include naltrexone-based combinations, melanocortin receptor 4 agonists (IMCIVREE), and pancreatic lipase inhibitors (XENICAL). The termination of rimonabant's development and withdrawal from European markets suggests that safety, efficacy, or commercial viability concerns outweighed the clinical rationale for CB1 antagonism in obesity management. Understanding rimonabant's trajectory is clinically relevant as a cautionary case study in obesity drug development and regulatory decision-making.
Drug intelligence
Drug Class: Cannabinoid receptor antagonist; Alimentary tract and metabolism agent (ATC A08)
Mechanism of Action: Selective antagonist of the cannabinoid CB1 receptor, which modulates appetite, energy expenditure, and metabolic regulation
Molecular Modality: Small molecule
Target: Cannabinoid receptor 1 (CB1)
Route of Administration: Not yet disclosed
Related Therapies: Other obesity treatments include GLP-1 receptor agonists (semaglutide, tirzepatide/Mounjaro), naltrexone-based combinations (ARX-NALTREXONE), melanocortin receptor 4 agonists (IMCIVREE), and lipase inhibitors (XENICAL)
First Approval: European Union, 17 July 2008 (subsequently withdrawn)
Patent Status: Not yet disclosed
obesity disorder
Also known as: obesity, obesity disease
Overview
A disorder involving an excessive amount of body fat.
Treatment landscape
ClinicalTrials.gov lists 50 registered studies for Obesity (Disorder) (AACT aggregate).
Phase breakdown: NA (46), PHASE4 (3), PHASE3 (1)
Common investigational therapies:
- Tirzepatide
- Placebo
- Semaglutide Pen Injector
- Semaglutide
- Gradual dose reduction of semaglutide
- Abrupt cessation of semaglutide
- GLP-1 Receptor Agonists
- GLP-1 Therapy
- Semaglutide (SEMA)
- Metoclopramide
Disease data sourced from MONDO Disease Ontology (MONDO:0011122), Orphanet — obesity disorder, NCT03412149, NCT06787001, NCT06852391, NCT06881485, NCT06911918, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Approved2008-07-17
EMA approval granted
Rimonabant (ZIMULTI) received European regulatory approval under two product numbers (EMEA/H/C/000666 and EMEA/H/C/000691).
- Phase 32016-06-08
Program terminated
The Phase 3 development program for rimonabant was terminated; specific reasons for termination are not disclosed.
Competitive landscape
The obesity pharmacotherapy market includes multiple mechanistic approaches. Approved competitors identified in the facts include ARX-NALTREXONE (opioid receptor antagonist combination from Lacuna Pharma), IMCIVREE (melanocortin receptor 4 agonist from Rhythm Pharmaceuticals), and XENICAL (pancreatic lipase inhibitor, also from Lacuna Pharma). Additionally, GLP-1 receptor agonists such as semaglutide-based formulations and tirzepatide (Mounjaro) represent the current standard-of-care agents for obesity, demonstrating superior weight loss efficacy compared to earlier-generation therapies. Rimonabant's CB1 antagonist mechanism represented a distinct pharmacological approach; however, the program's termination and market withdrawal suggest that competitive, safety, or efficacy factors rendered it non-viable in the evolving obesity treatment landscape. The shift toward incretin-based therapies has substantially altered the competitive dynamics since rimonabant's initial approval.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| ARX-NALTREXONE | Lacuna Pharma Pty Ltd | Opioid receptors; mu/kappa/delta antagonist | approved |
| IMCIVREE | Rhythm Pharmaceuticals Netherlands B.V. | Melanocortin receptor 4 agonist | approved |
| XENICAL | Lacuna Pharma Pty Ltd | Pancreatic lipase inhibitor | approved |
| Simvastatin | Hospital Authority, Hong Kong | small_molecule | approved |
| Pioglitazone | Takeda | small_molecule | approved |
| Semaglutide B 3.0 mg/ml PDS290 | Disc Medicine | small_molecule | approved |
| Mounjaro solution for injection in pre-filled... for Obesity | The George Institute | small_molecule | approved |
| ESOMEPRAZOLE, ESOMEPRAZOLE | Fondazione Telethon ETS | small_molecule | approved |
| Candesartan and Hydrochlorothiazide | Takeda | small_molecule | approved |
| NN9838-4968 | NovoThirteen | small_molecule | approved |
| Intravenous Ibuprofen | CUMBERLAND PHARMACEUTICALS INC | small_molecule | approved |
| NN9536-7752 | NovoThirteen | small_molecule | approved |
| SIBUTRAMINE | — | Monoamine transporter inhibitor | Approved |
| SETMELANOTIDE ACETATE | — | Melanocortin receptor 4 agonist | Approved |
| SETMELANOTIDE | — | Melanocortin receptor 4 agonist | Approved |
| RIMONABANT | — | Cannabinoid CB1 receptor antagonist | Approved |
| PHENTERMINE HYDROCHLORIDE | — | Norepinephrine transporter releasing agent | Approved |
| PHENTERMINE | — | Norepinephrine transporter releasing agent | Approved |
| PHENDIMETRAZINE TARTRATE | — | Norepinephrine transporter inhibitor | Approved |
| ORLISTAT | — | Pancreatic lipase inhibitor | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
European Union: Rimonabant (ZIMULTI) received marketing authorization on 17 July 2008 under two EMA product numbers: EMEA/H/C/000666 and EMEA/H/C/000691, with marketing authorization holder Sanofi-Aventis. The product was subsequently withdrawn from the EU market.
United States FDA: Regulatory status not yet disclosed.
Japan PMDA: Regulatory status not yet disclosed.
China NMPA: Regulatory status not yet disclosed.
The European approval was followed by market withdrawal, indicating that post-authorization safety or commercial concerns led to discontinuation of the product in the EU market.
Clinical evidence summary
Key questions answered
What is rimonabant (ZIMULTI) used for?
Rimonabant is a cannabinoid CB1 receptor antagonist developed for the treatment of obesity by reducing appetite and modulating energy expenditure.
Is rimonabant currently approved for use?
Rimonabant received European Union marketing authorization on 17 July 2008 but was subsequently withdrawn from the market. It is not approved in the United States or other major regulatory jurisdictions based on available records.
How does rimonabant work?
Rimonabant selectively antagonizes the cannabinoid CB1 receptor, which plays a role in appetite regulation and metabolic homeostasis, thereby reducing hunger and promoting weight loss.
Who manufactures rimonabant?
Rimonabant was developed and sponsored by Sanofi Pasteur (with marketing authorization held by Sanofi-Aventis in the European Union).
What is the drug's molecular modality?
Rimonabant is a small-molecule pharmaceutical compound.
What is the target of rimonabant?
Rimonabant targets the cannabinoid receptor 1 (CB1), a G-protein coupled receptor involved in appetite and energy metabolism.
What development phase was rimonabant in when the program was terminated?
Rimonabant was in Phase 3 clinical development when the program was terminated on 8 June 2016.
Why was rimonabant's development program terminated?
The specific reasons for termination are not disclosed in available records; however, the decision occurred after initial European approval and market withdrawal, suggesting safety, efficacy, or commercial concerns.
What clinical trials were conducted for rimonabant?
A Phase 3 trial (NCT00478972) is identified in the records, but detailed trial design, outcomes, and results are not yet disclosed.
What are the main competitors to rimonabant in obesity treatment?
Competitors include GLP-1 receptor agonists (semaglutide, tirzepatide/Mounjaro), naltrexone-based combinations (ARX-NALTREXONE), melanocortin receptor 4 agonists (IMCIVREE), and pancreatic lipase inhibitors (XENICAL).
What is the therapeutic classification of rimonabant?
Rimonabant is classified as an alimentary tract and metabolism agent (ATC code A08).
Was rimonabant approved in the United States?
United States FDA regulatory status for rimonabant is not yet disclosed in available records.
What was the European approval date for rimonabant?
Rimonabant received European Union marketing authorization on 17 July 2008 under two EMA product numbers (EMEA/H/C/000666 and EMEA/H/C/000691).
Is rimonabant still being developed?
No; the rimonabant development program was terminated on 8 June 2016, and no further development milestones are anticipated.
What route of administration was planned for rimonabant?
The route of administration for rimonabant is not yet disclosed in available records.
Does rimonabant have any active partnerships?
No active partner is identified for the rimonabant program in available records; development was sponsored by Sanofi Pasteur.
Entity relationship graph
Rimonabant → Drug → Target → Indication → Company → Trials → Competitors
Drugs
Molecular targets
Companies
Indication
Trials
Competitors
- ARX-NALTREXONE
- IMCIVREE
- XENICAL
- Simvastatin
- Pioglitazone
- Semaglutide B 3.0 mg/ml PDS290
- Mounjaro solution for injection in pre-filled... for Obesity
- ESOMEPRAZOLE, ESOMEPRAZOLE
- Candesartan and Hydrochlorothiazide
- NN9838-4968
- Intravenous Ibuprofen
- NN9536-7752
- SETMELANOTIDE ACETATE
- SETMELANOTIDE
- RIMONABANT
- PHENTERMINE HYDROCHLORIDE
- PHENTERMINE
- PHENDIMETRAZINE TARTRATE
- ORLISTAT
Analyst insights
Strategic Implications: Rimonabant's termination and market withdrawal represent a significant setback for CB1 receptor antagonism as an obesity treatment strategy. The program's failure occurred despite initial European regulatory approval, suggesting that post-marketing safety signals, efficacy concerns in later-phase trials, or commercial viability issues prompted the decision to discontinue development. The timing of termination (June 2016) coincides with the rising clinical prominence of GLP-1 receptor agonists, which have since become the dominant pharmacological approach to obesity management.
Competitive Implications: The obesity treatment landscape has consolidated around GLP-1 and GIP receptor agonists, which demonstrate superior efficacy and tolerability profiles compared to earlier-generation agents including CB1 antagonists. Rimonabant's failure underscores the challenge of competing in a market increasingly dominated by incretin-based therapies with robust clinical evidence and strong commercial adoption.
Future Catalysts: No further development milestones are anticipated for rimonabant, as the program remains terminated. The case serves as a historical reference point for understanding regulatory and commercial decision-making in obesity drug development.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is rimonabant?
- A small-molecule cannabinoid CB1 receptor antagonist developed for obesity treatment.
- Who developed rimonabant?
- Sanofi Pasteur (marketing authorization holder: Sanofi-Aventis in EU).
- What is rimonabant's indication?
- Obesity.
- What is rimonabant's mechanism of action?
- Cannabinoid CB1 receptor antagonist.
- What is rimonabant's target?
- Cannabinoid receptor 1 (CB1).
- What is rimonabant's modality?
- Small molecule.
- What development phase was rimonabant in?
- Phase 3 (terminated 8 June 2016).
- Is rimonabant approved?
- EU approved 17 July 2008, subsequently withdrawn; US status not disclosed.
- What is rimonabant's brand name?
- ZIMULTI.
- What is rimonabant's current status?
- Program terminated; development discontinued.
- Does rimonabant have a partner?
- No active partner identified; Sanofi Pasteur is sole sponsor.
- What is rimonabant's route of administration?
- Route of administration not yet disclosed.
- What clinical trial supports rimonabant?
- Phase 3 trial NCT00478972; detailed results not yet disclosed.
- What are rimonabant's main competitors?
- GLP-1 agonists (semaglutide, tirzepatide), IMCIVREE, ARX-NALTREXONE, XENICAL.
- Why was rimonabant terminated?
- Specific reasons not disclosed; likely safety, efficacy, or commercial concerns.
- What is rimonabant's EMA product number?
- EMEA/H/C/000666 and EMEA/H/C/000691.
- When was rimonabant approved in Europe?
- 17 July 2008.
- When was rimonabant's program terminated?
- 8 June 2016.
- What is rimonabant's therapeutic class?
- Alimentary tract and metabolism agent (ATC A08).
- Is rimonabant available for prescription?
- No; program terminated and EU market withdrawn.
- What is the internal code for rimonabant?
- EFC6648.
- Does rimonabant have patent protection?
- Patent status not yet disclosed.
Evidence & sources
- ClinicalTrials.gov NCT00478972 (clinicaltrials)
- rimonabant EU status (ema)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0011122) (mondo)
- Orphanet — obesity disorder (orphanet)
- NCT03412149 (clinicaltrials_gov)
- NCT06787001 (clinicaltrials_gov)
- NCT06852391 (clinicaltrials_gov)
- NCT06881485 (clinicaltrials_gov)
- NCT06911918 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.